assessment of the efficacy of the neoadjuvant combination: "chemotherapy-targeted therapy" in breast cancer.

Conditions: Pathological Response Rate

Summary: the purpose of this study is to assess the pathological response rate in operable breast cancer patients treated by neoadjuvant combination: "fec-taxotere/vectibix".


Eligibility criteria:
inclusion criteria: * age ³ 18.- performance status £ 2 (according to who criteria). * patient has histologically confirmed, non-metastatic breast cancer, with a clinical tumour diameter of ³ 2 cm * hr negative and her-2 negative. * clinical stage ii and iiia. * patients not previously treated by surgery, radiotherapy, hormone therapy or chemotherapy.· haematology: o neutrophil count ≥1.5x109/lo platelet count ≥100x109/lo leucocyte count \> 3,000/mmo hb\> 9g/dl· hepatic function:o total bilirubin ≤ 1.5 time the upper normal limit (unl)o asat ≤ 2.5xunl in absence of liver metastases, or ≤5xunl in presence of liver metastases alat ≤ 2.5xunl in absence of liver metastases, or ≤5xunl in presence of liver metastases alkaline phosphatase ≤ 2.5 time the upper normal limit (unl)· renal function· creatinine clearance ≥50 ml/min and serum creatinine ≤1.5xunl· metabolic function o magnesium ≥ lower limit of normal. o calcium ≥ lower limit of normal. * patient with no progressive heart disease, and for whom anthracyclines are not contraindicated (normal fev). * patient has signed the consent forms for participation before inclusion in the trial. * member of a social security scheme (or a beneficiary of such a scheme) according to the provisions of the law of 9 august 2004. exclusion criteria: * male patients. * her-2 positive patients * subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment. * subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment. * any form of breast cancer other than those described in the inclusion criteria, particularly inflammatory and/or overlooked forms (t4b or t4d). * non-measurable tumour. * patients have already undergone surgery for their disease or have had primary axillary dissection. * patient has already been treated for new breast cancer. * patient is a ward. * patient has a history of second cancer, with exception of in situ cervical cancer or basocellular skin cancer which is regarded as cured. * patient has another disease which is deemed incompatible with the patient being included in the protocol. * heart or kidney failure, medullary, respiratory or liver failure. * clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) £ 1 year before enrollment/randomization * history of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest ct scan * significant neurological or psychiatric abnormalities. * symptomatic or progressive disorder of the central nervous system (cns) or metastasis at the initial check-up. * peripheral neuropathy \> grade 2 (nci-ctcae criteria, version 3.0). * history of allergy to polysorbate 80. * concomitant treatment with a trial drug, participation in another clinical trial within \< 30 days or previous chemotherapy. * patient with no fixed address in the next 6 months or living at a distance from the treatment centre so it is difficult to check her progress. * prior anti-egfr antibody therapy (e.g.:cetuximab) or treatment with small molecule egfr tyrosine kinase inhibitors (e.g.: erlotinib). * known previous or ongoing abuse of narcotic drug, other medication or alcohol. * any investigational agent within 30 days before initiation of study treatment. - must not have had a major surgical procedure within 28 days of initiation of treatment. * subject unwilling or unable to comply with study requirements.

Keywords: breast cancer, neoadjuvant therapies, chemotherapy, targeted therapy